Cancellous Bone Autograft, Bone Substitute, Local Antibiotic, and Fresh Blood for Ununited Fixed Femoral and Tibial Fractures

NCT07561788 | Completed

• 1 other identifier: 3626PR706/5/24
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to assess the clinical and radiological outcomes of the usage of autogenous bone graft mixed with bone substitute, fresh blood of patient and local antibiotic used as an onlay graft in treatment of nonunion or delayed union of fixed femoral and tibia fractures.

Conditions

Cancellous Bone Autograft; Bone Substitute; Local Antibiotic; Fresh Blood; Ununited Fixed Femoral and Tibial Fractures

Outcome Measures

Primary Outcomes (1)

• Radiographic union of the fractures

  Radiographic follow-up included evaluating Radiographic Union Score for Tibial Fractures (RUST) were used system to objectively evaluate tibial fractures. RUST assesses union based on four radiographic features: the presence of callus formation, cortical bridging, trabecular bridging, and the degree of alignment at the fracture site. Each feature was scored individually on a scale of 0 to 4, with higher scores indicating better healing.

  6 months post-procedure

Secondary Outcomes (3)

• Time to union

  Till full fracture healing (Up to 6 months)

• Degree of pain

  12 months post-procedure

• Incidence of postoperative complications

  12 months post-procedure

Study Arms (1)

Study group

Adult individuals underwent revision surgery for non-union of femoral or tibial shaft fractures following definitive fixation by intramedullary nails or Illizarov fixators

Procedure: Revision using a composite graft

Interventions

Revision using a composite graft PROCEDURE

All patients underwent revision using a composite graft and either retained intramedullary nails or Ilizarov fixators.

Study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective trial was performed on 25 adult individuals underwent revision surgery for non-union of femoral or tibial shaft fractures following definitive fixation by intramedullary nails or Illizarov fixators according to the local potential infection presence.

You may qualify if:

• Age from 18 to 70 years old.
• Both sexes.
• Patients with complete radiographic and clinical follow-up records for at least 12 months post-revision.

You may not qualify if:

• \- Patients with pathological fractures, infection, or comorbidities that interfere with healing.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Orthopedic Surgery, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: July 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)